Reducing Regulatory Burden and Streamlining FDA Review Through ASCA Pilot Program Utilization

Agenda

During this webinar, the FDA will highlight how the ASCA Pilot Program streamlines aspects of conformity assessments for medical device submissions, as well as what manufacturers can expect when they submit ASCA test results to the government agency.

This online event, 60 minutes in length, will also allot time for Q&A with the FDA and NAMSA.

The webinar will answer the following questions:

• What are the benefits of participating in the ASCA Pilot Program?
• How does ASCA work, and what does the FDA expect from a submission with ASCA testing?
• What difference will ASCA make in submission development and overall process?
• What submission types and devices are eligible for the ASCA Pilot Program?
• Where do I find additional ASCA resources?

Speakers

Shulang Li

ASCA Testing Laboratory Lead – Biocompatibility

Shuliang Li received her Ph.D. in Chemical Engineering from University of Notre Dame. Before she joined FDA, she worked in the medical device industry for six years.  She joined the FDA in 2013 and worked as a lead reviewer in the Orthopedic Device Division at CDRH. Dr. Li then moved into a Senior Standards Advisor position at Standards and Conformity Assessment Program at CDRH. She currently serves as the Biocompatibility Test Lab Lead in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. Dr. Li has led multiple medical device standards activities in the area of Biocompatibility, Materials, Tissue Engineering. She is the CDRH lead for U.S. Pharmacopeia standards and the primary liaison for ISO TC 150 Fundamental Standards.  She currently serves on the ANSI Executive Standards Council.

Jennifer Goode

Biocompatibility Program Advisor, Office of Product Evaluation and Quality (OPEQ), FDA, Center for Devices and Radiologic Health (CDRH)

Jennifer L. Goode, BS, Biomedical Engineer has served as the Biocompatibility Program Advisor for OPEQ (formerly ODE) since 2015, and most recently provided biocompatibility technical and regulatory policy input for the ASCA Biocompatibility Testing Laboratory Accreditation process. Ms. Goode began her career at CDRH in 1994, as a premarket reviewer responsible for the review of medical devices and combination products for surgical and interventional treatment of the peripheral vasculature, as well as cardiac monitoring, pacing, neurology and obstetrics and gynecology devices. Beginning in 2007, Ms. Goode served as an FDA liaison to and International Expert for several ISO Working Groups responsible for the development of international standards for the biocompatibility evaluation of medical devices, including ISO 10993-1, ISO 10993-4, and ISO 10993-18. Since 2017, Ms. Goode has represented CDRH on the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a committee responsible for coordination of review and acceptance of fit for purpose new or revised toxicology test methods that reduce, refine, or replace the use of animals. In 2018, Ms. Goode was selected as FDA’s Alternate Agency Representative to ICCVAM.  Since 2018, Ms. Goode began serving as the CDRH regulatory expert for the USP Biocompatibility Expert Panel tasked with revision of General Chapters <87>, <88>, and <1031>. In 2020, she was identified as an expert government liaison to USP’s Packaging Expert Committee. Since 2018, Ms. Goode has also served as the regulatory co-chair for the US AAMI Biological Evaluation (BE) mirror committee to ISO/TC 194. The AAMI/BE committee is responsible for coordinating US positions on all ISO standards related to biocompatibility evaluation of medical devices. Since 2008, Ms. Goode also began serving as one of two OPEQ representatives to the Biocompatibility Standards Task Group (STG) at CDRH. This Biocompatibility STG is responsible for coordinating FDA input to, and scientific review and recognition of all biocompatibility standards used by CDRH.

Melissa Cadaret

Director of Global Compliance and Process Improvement

Melissa’s past experience includes serving as the Director of Analytical Services and Biocompatibility Laboratory Operations and Site Leadership for NAMSA’s Global Headquarters in Northwood (Toledo), Ohio. With more than 15 years of biocompatibility experience, Melissa is also currently a U.S. Expert on ISO TC 194: Biological Evaluation Medical Devices ANSI / AAMI/ ISO 10993. Melissa has a MS in Molecular Biology from Bowling Green State University and Bachelor’s degree in Biology from Southern Illinois University.